Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Completed · Phase 3
Conditions studied: Graft Rejection
In brief
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.
Key facts
- Study ID
- NCT00097968
- Run by
- Novartis Pharmaceuticals
- Starts
- 2004-08-01
- Last updated by the study team
- 2010-07-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.
- Patient must be on statins at study entry.
- Patient who is more than 12 months post-transplant.
You may not qualify if…
- Patient with a serum creatinine value >2.0 mg/dL.
- Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months prior to study entry.
- Patient who had received any investigational drug within 4 weeks prior to study entry.
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- University of Minnesota, Fairfield University Hospital — Minneapolis, Minnesota, United States
- Columbia Presbyterian Medical Center — New York, New York, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- Midstate Cardiology — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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